Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Rules and Regulations 19665 

paragraph (1)(i), redesignating (1)(ii) and 

(1)(iii) as (1)(i) and (1)(ii), respectively, 

and revising paragraph (12) to read as 

follows: 

§ 1.1 General definitions. 

* * * * * 

Light-sport aircraft * * * 

* * * * * 

(12) Fixed or retractable landing gear, 

or a hull, for an aircraft intended for 

operation on water. 

* * * * * 

Issued in Washington, DC, on April 9, 

2007. 

Marion C. Blakey, 

Administrator. 

[FR Doc. E7–7453 Filed 4–18–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Withdrawal 

of Approval of NADAs; Estradiol 

Benzoate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations that reflect 

approval of two new animal drug 

applications (NADAs) for a suspension 

implant of estradiol benzoate 

microspheres used in steers and heifers 

fed in confinement for slaughter for 

increased rate of weight gain and 

improved feed efficiency, and in 

suckling beef calves for increased rate of 

weight gain. In a notice published 

elsewhere in this issue of the Federal 

Register, FDA has withdrawn approval 

of the NADAs. 

DATES: This rule is effective April 19, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–212), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–276–

9067; e-mail: 

pamela.esposito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: PR 

Pharmaceuticals, Inc., 1716 Heath 

Pkwy., Fort Collins, CO 80524, has 

requested that FDA withdraw approval 

of NADA 141–040 for DURALEASE 

(estradiol benzoate), a suspension 

implant of estradiol benzoate 

microspheres used in steers and heifers 

fed in confinement for slaughter for 

increased rate of weight gain and 

improved feed efficiency and NADA 

141–041 for CELERIN-C (estradiol 

benzoate), a similar product used in 

suckling beef calves for increased rate of 

weight gain. This action is requested 

because the products are no longer 

manufactured or marketed. 

In a notice published elsewhere in 

this issue of the Federal Register, FDA 

gave notice that approval of NADA 141–

040 and NADA 141–041 and all 

supplements and amendments thereto, 

were withdrawn, as of September 29, 

2006. 

Following the withdrawal of approval 

of these NADAs, PR Pharmaceuticals, 

Inc., is no longer a sponsor of an 

approved application. Therefore, 21 

CFR 510.600(c) is amended to remove 

entries for this firm. As provided in the 

regulatory text of this document, the 

animal drug regulations are amended to 

reflect the withdrawal of approval. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510 and 522 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entry for 

‘‘PR Pharmaceuticals, Inc.’’; and in the 

table in paragraph (c)(2) remove the 

entry for ‘‘067210’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.841 [Removed] 

■ 4. Remove § 522.841. 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7458 Filed 4–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 558 

New Animal Drugs For Use in Animal 

Feed; Withdrawal of Approval of 

NADAs; Pyrantel; Tylosin; Tylosin and 

Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of three new animal drug 

applications (NADAs) for intermediate 

premixes used to manufacture Type C 

medicated feeds. In a notice published 

elsewhere in this issue of the Federal 

Register, FDA is withdrawing approval 

of the NADAs. 

DATES: This rule is effective April 30, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–212), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–276–

9067, e-mail: 

pamela.esposito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Custom 

Feed Services Corp., 2100 N. 13th St., 

Norfolk, NE 68701, has requested that 

FDA withdraw approval of NADA 121–

200 for Tylosin 10 Premix (tylosin), 

NADA 129–159 for TYLAN 40 Sulfa-G 

(tylosin and sulfamethazine), and 

NADA 137–484 for Swine Guard-BN 

(pyrantel). All are intermediate 

premixes used to manufacture Type C 

medicated feeds. This action is 

requested because the products are no 

longer manufactured or marketed. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

gives notice that approval of NADA 


cprice-sewell on PROD1PC66 with RULES